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NCT ID: NCT02957786 Completed - Smoking Cessation Clinical Trials

Cytisine Versus Varenicline for Smoking Cessation

RAUORA
Start date: September 18, 2017
Phase: Phase 3
Study type: Interventional

To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.

NCT ID: NCT02956850 Completed - Clinical trials for Hepatitis B, Chronic

A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531

Start date: December 12, 2016
Phase: Phase 1
Study type: Interventional

This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers. Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants.

NCT ID: NCT02952924 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants

Start date: December 14, 2016
Phase: Phase 1
Study type: Interventional

This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. Part 3 is a non-randomized, non-controlled, open-label part to assess the efficacy and safety of RO7049389 when administered in combination with standard-of-care therapies for up to 48 weeks in nucleos(t)ide (NUC)-suppressed and treatment-naive chronic hepatitis B (CHB) participants.

NCT ID: NCT02952820 Completed - Insomnia Disorder Clinical Trials

Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

Start date: November 15, 2016
Phase: Phase 3
Study type: Interventional

The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.

NCT ID: NCT02948010 Completed - Clinical trials for Obstructive Sleep Apnea

CPAP Device In-lab Assessment NZ

Start date: November 2016
Phase: N/A
Study type: Interventional

The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

NCT ID: NCT02947269 Completed - Clinical trials for Postoperative Complications

Prucalopride in Postoperative Ileus

Start date: October 25, 2017
Phase: Phase 3
Study type: Interventional

Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after abdominal surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting, are unable to open their bowels and have a prolonged hospital stay. Research at ADHB shows that 25% of patients will have a prolonged POI after elective bowel resection, which makes it the most common major complication after colorectal surgery. Clinicians currently lack a definitive medication to prevent or treat POI, which means POI causes patients ongoing morbidity and places a significant drain on healthcare resources. Serotonin plays an important role in gut motility. Evidence suggests that serotonin agonists, such as prucalopride, increase gut transit and may have anti-inflammatory properties. The hypothesis of this study is that Prucalopride given pre-operatively and continued post-operatively in patients having an elective bowel resection will improve gut function recovery after surgery and reduce POI. The investigators' proposed study is a double-blinded randomised controlled trial of prucalopride compared to an identical placebo tablet, in patients having an elective bowel resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride or placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days. The primary endpoint will be return to bowel function defined by the time to tolerate a solid diet and pass stool. In addition, the investigators plan to assess postoperative gastric emptying rates using the safe and non-invasive carbon breath test method. This will allow the investigators to determine the effects of prucalopride on the stomach, and support its role as a gastric prokinetic.

NCT ID: NCT02943239 Completed - Healthy Volunteers Clinical Trials

Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

Start date: December 7, 2016
Phase: Phase 1
Study type: Interventional

The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033. The secondary objectives are to: - Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume - Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition - Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033 - Assess immunogenicity of REGN2477 or REGN1033 - Assess REGN2477 or REGN1033 target engagement

NCT ID: NCT02942966 Completed - Clinical trials for Peripheral Arterial Disease

Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries

TOBA II BTK
Start date: February 8, 2017
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

NCT ID: NCT02942446 Completed - Clinical trials for Obstructive Sleep Apnea

Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

Start date: October 2016
Phase: N/A
Study type: Interventional

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

NCT ID: NCT02939989 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study

MAGELLAN-3
Start date: November 21, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.